Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -2 Question 1: What does accuracy of an analytical procedure express? Answer 1: The accuracy of an analytical procedure expresses the closeness of agreement between the value accepted as a true or reference value and the value found. It is sometimes referred to as…
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Q&A ON VALIDATION OF ANALYTICAL PROCEDURES – ICH Q2 GUIDELINE PART -1 Question 1: What is the objective of validation of an analytical procedure according to the ICH Q2? Answer 1: The objective of validation of an analytical procedure is to demonstrate its suitability for its intended purpose. Question 2: What is the scope of…
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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -10 Question 1: What is the purpose of management review regarding process performance and product quality? Answer 1: The purpose of management review regarding process performance and product quality is to provide assurance that these aspects are managed effectively over the lifecycle of the…
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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -9 Question 1: How should changes be managed in the pharmaceutical development stage? Answer 1: Changes in the pharmaceutical development stage should be an inherent part of the process and documented accordingly. The formality of the change management process should be consistent with the…
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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -8 Question 1: What types of actions should be implemented through the CAPA system according to the ICH Q10? Answer 1: The CAPA system should implement corrective actions and preventive actions resulting from the investigation of various issues such as complaints, product rejections, non-conformances,…
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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -7 Question 1: Why is it important for pharmaceutical companies to implement a system for monitoring process performance and product quality? Answer 1: It is important for pharmaceutical companies to implement such a system to ensure a state of control is maintained. This system…
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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -6 Question 1: What are the four elements of the pharmaceutical quality system described in the ICH Q10? Answer 1: The four elements of the pharmaceutical quality system described in the ICH Q10 are: Process performance and product quality monitoring system Corrective action and…
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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -5 Question 1: What is management responsible for regarding resource management according to the ICH Q10? Answer 1: Management is responsible for determining and providing adequate and appropriate resources (human, financial, materials, facilities, and equipment) to implement and maintain the pharmaceutical quality system and…
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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -4 Question 1: What role does leadership play in ensuring the effectiveness of a pharmaceutical quality system? Answer 1: Leadership is essential for establishing and maintaining a company-wide commitment to quality and for the performance of the pharmaceutical quality system. Question 2: What is…
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Q&A on Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -3 Question 1: Why is it important for the design, organization, and documentation of the pharmaceutical quality system to be well structured and clear? Answer 1: It is important for the design, organization, and documentation of the pharmaceutical quality system to be well structured…
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Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -2 Question 1: What is the primary aim of implementing a system according to the ICH Q10 guideline? Answer 1: The primary aim of implementing a system, is to ensure the delivery of products with quality attributes suitable to meet the needs of patients, healthcare professionals,…
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Pharmaceutical Quality System (PQS) – ICH Q10 guideline Part -1 Question 1: What is the main focus of the Pharmaceutical Quality System (PQS) outlined in the ICH Q10 guideline? Answer 1: The main focus of the Pharmaceutical Quality System (PQS) described in the ICH Q10 guideline is to establish an effective quality management system within…
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STORAGE OF BULK AND SEMI-FINISH TABLETS
Critical Area – Class 100 (ISO 5) AS PER USFDA GUIDELINE A critical area is one in which the sterilized drug product, containers, and closures are exposed to environmental conditions that must be designed to maintain product sterility (§ 211.42(c)(10)). Activities conducted in such areas include manipulations (e.g., aseptic connections, sterile ingredient additions) of sterile…
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VALIDATION OF ASEPTIC PROCESSING AS PER USFDA GUIDELINE Process Simulations To ensure the sterility of products purporting to be sterile, sterilization, aseptic filling, and closing operations must be adequately validated (§ 211.113). The goal of even the most effective sterilization processes can fail to achieve their objective if the sterilized components of a product, such…
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Air Filtration – High-Efficiency Particulate Air (HEPA) As Per USFDA GUIDELINE HEPA filter integrity should be maintained to ensure aseptic conditions. Leak testing should be performed at installation to detect integrity breaches around the sealing gaskets, through the frames, or at various points on the filter media. Thereafter, leak tests should be performed at suitable…
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Air Filtration by Membrane AS PER USFDA GUIDELINE Air Filtration by Membrane – A compressed gas should pass for purity test to ensure it is free from oil and meets the required standards for microbiological and particle quality after filter. The quality of the compressed gas should be at least equal to the air quality…
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Alcoa++ In a world where data plays a crucial role in decision-making and technological advancements shape various industries, the significance of data integrity cannot be emphasized enough. Alcoa, a company renowned for its commitment to excellence, extends the principles of Alcoa Plus Plus beyond aluminum production to prioritize data integrity as a fundamental aspect of…
CIP -Cleaning In Place CIP, also known as Cleaning In Place, is a methodical and automated technique used to clean the inner surfaces of manufacturing equipment, including tanks, pipes, and vessels, without the need for disassembly. This approach is extensively utilized in the pharmaceutical sector to remove any remnants of the previous product, cleaning agents,…
RECEIVING OF RAW MATERIALS FROM THE DISPENSING AREA TO THE PRODUCTION DAY STORE AREA
